Fever MalariaNCT04791800
Clinical Evaluation of the STANDARD™ Q Malaria/CRP Duo Test
An observational study of Fever Malaria, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in India.
Trial summary
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Fever Malaria
- What is being tested?
- Malaria/CRP combination test
- How many people
- 1,808 participants
- Where
- 1 siteIndia
- Study dates
- 8 Apr 2019to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients aged 5 years and above with clinically suspected malaria on the basis of fever or history of fever in the previous 72 h, either enrolled by passive case detection in health care facilities, or by active case detection in the surrounding communities.
Who may be able to join
- clinically suspected malaria on the basis of fever or history of fever in the previous 72 h
- age ≥ 5 years, (iii) having been informed of the study and signed a written consent form
Who cannot join
- signs of severe malaria or other severe disease
- patients not fulfilling the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Performance of the STANDARD™ Q Malaria/CRP Duo Test (SD Biosensor, South Korea) for the Diagnosis of Malaria and the Detection of C-reactive Protein (CRP) in Fingerprick Blood of Febrile Patients
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available C-Reactive Protein (CRP) test kit run on a laboratory machine as a reference test for CRP.
- Conditions
- Fever Malaria
- Being tested
- Malaria/CRP combination test
- Keywords
- malaria, fever, C-reactive protein, point-of-care testing
- Medical subject headings
- Malaria, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria/CRP combination testDiagnostic test
Testing with a malaria/CRP combination test, in parallel with a standard malaria RDT (to guide case management), preparation of thin/thick films for expert malaria microscopy, and collection of venous blood for subsequent CRP quantification.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of the Malaria/CRP combination test for malaria diagnosis at day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the diagnosis of malaria, in comparison with expert microscopy as the reference test at day 0 (first day of presentation).
Measured: Day 0
Clinical performance of the Malaria/CRP combination test for detection of high levels of C-reactive protein at day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the detection of CRP at day 0, in comparison with the CRP-LX reagent kit used with the Roche Diagnostics Cobas™ c111 chemistry analyser, or equivalent, as the reference test.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start8 Apr 2019
- Primary completion16 Mar 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fever MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Malaria Research, New Delhi, India
- Responsible party
- Sponsor
- Investigators
- Anupkumar Anvikar, MD, Principal investigator, National Institute of Malaria Research, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791800
- Sponsor's protocol ID
- 8820-2/1
- Status last verified
- Mar 2021
- First submitted
- 10 Aug 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of the STANDARD™ Q Malaria/CRP Duo Test (SD Biosensor, South Korea) for the Diagnosis of Malaria and the Detection of C-reactive Protein (CRP) in Fingerprick Blood of Febrile Patients
- ClinicalTrials.gov ID
- NCT04791800
- Acronym / sponsor ID
- 8820-2/1
- Conditions
- Fever Malaria
- Keywords
- malaria, fever, C-reactive protein, point-of-care testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,808 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- National Institute of Malaria Research, New Delhi, India
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available C-Reactive Protein (CRP) test kit run on a laboratory machine as a reference test for CRP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 5 years and above with clinically suspected malaria on the basis of fever or history of fever in the previous 72 h, either enrolled by passive case detection in health care facilities, or by active case detection in the surrounding communities.
Key inclusion criteria (2 listed)
- clinically suspected malaria on the basis of fever or history of fever in the previous 72 h
- age ≥ 5 years, (iii) having been informed of the study and signed a written consent form
Key exclusion criteria (2 listed)
- signs of severe malaria or other severe disease
- patients not fulfilling the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malaria/CRP combination testTesting with a malaria/CRP combination test, in parallel with a standard malaria RDT (to guide case management), preparation of thin/thick films for expert malaria microscopy, and collection of venous blood for subsequent CRP quantification. | Diagnostic test | – |
Primary outcome
Clinical performance of the Malaria/CRP combination test for malaria diagnosis at day 0
Time frame: Day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the diagnosis of malaria, in comparison with expert microscopy as the reference test at day 0 (first day of presentation).
Clinical performance of the Malaria/CRP combination test for detection of high levels of C-reactive protein at day 0
Time frame: Day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the detection of CRP at day 0, in comparison with the CRP-LX reagent kit used with the Roche Diagnostics Cobas™ c111 chemistry analyser, or equivalent, as the reference test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anupkumar Anvikar, MD principal investigator
National Institute of Malaria Research, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever Malaria, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of the Malaria/CRP combination test for malaria diagnosis at day 0 (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.